FDA DeviceClass IINotable

FDA Recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog

Date: 2026-04-29
Brand: Angiodynamics, Inc.
Category: Medical Device
FDA Class: Class II

Description

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Hazard

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Remedy

1520 units (304 boxes)

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